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Unapproved cough and cold medicines linked to infant deaths.(Recalls & Safety Alerts)(Brief article)
The Food and Drug Administration has ordered drug companies to stop producing unapproved cough and cold remedies that contain carbinoxamine, an older sedating antihistamine linked to the deaths of 21 children under 2 years of age.
Such frequently prescribed cough and cold combinations as Carbaxefed DM RF and Carbofed DM have contained carbinoxamine. Yet the FDA says it has not deemed carbinoxamine safe and effective for that particular use.
Carbinoxamine was developed in the 1950s, before federal law established today's drug-approval process. Since then, the antihistamine has turned up in more than 120 prescription products, many marketed for infants.
The FDA has received reports of 21 infant deaths linked to carbinoxamine-containing products since 1983, but a cause-and-effect relationship has not been established.
"Carbinoxamine has never been studied in very young children, and FDA cannot predict how they will respond to it," the agency warned in a June 8 statement.
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